1. BASIS OF CONTRACT FOR SUPPLY. Leiters shall Supply to Customer, and Customer shall purchase from Leiters, Product(s) in accordance with these Conditions, to the exclusion of all other terms and conditions (whether of Customer or otherwise). No order submitted by Customer shall be deemed to be accepted by Leiters, no Contract for Supply shall exist, and no obligation or commitment of Leiters shall arise, whether in respect of any quotation by Leiters or otherwise, unless and until an order submitted by Customer is acknowledged, confirmed, filled or otherwise accepted by Leiters, whereupon a Contract incorporating these Conditions shall exist. No Special Terms or any other variation to these Conditions or any applicable Contract shall be binding upon Leiters unless agreed to in Writing between Customer and Leiters, and any Special Terms so agreed upon which contradict these Conditions shall prevail over these Conditions. Definitions of capitalized terms are set forth at the end of these Conditions.
2. QUOTATIONS AND PRICES. Any quotation given by Leiters incorporates these Conditions. The price of the Supply of Product(s) shall be Leiters’ price in any relevant quotation or, where no price has been quoted (or a quoted price is no longer valid), the price listed in Leiters’ published price list existing on the date of Leiters’ acceptance of Customer’s order.
3. PURCHASE ORDERS. Customer is responsible for: (a) the accuracy of the terms in any order; (b) where applicable, ensuring that any Specifications in any quotation from Leiters are complete and correct and/or meet the requirements of Customer; and (c) giving Leiters accurate, complete and correct information relating to Customer’s requirements for the Supply of Product(s). Each order submitted by Customer shall be deemed to incorporate these Conditions, shall comply with all Applicable Laws, shall be signed by Customer, and shall specify the quantity of each Product to be Supplied, the destination, the price and delivery date, and such other information necessary to effect delivery of each Product. NO ADDITIONAL PRE-PRINTED TERMS OR CONDITIONS CONTAINED IN EITHER PARTY’S PURCHASE ORDERS, ORDER CONFIRMATIONS, INVOICES, QUOTATIONS OR ANY OTHER FORMS SHALL APPLY.
4. DELIVERY. Leiters shall deliver Product to Customer FOB Leiters’ facility. Except as otherwise provided in Writing or an applicable Leiters promotion, Customer shall be responsible for all freight, import/export, broker, duty, fee, and tax costs associated with shipping Product from Leiters’ facility to Customer’s designated location. Title to and all risk of loss of or damage to Product shall pass to Customer upon delivery. Any dates quoted or agreed for delivery of Product are approximate only, and Leiters shall not be liable for any delay in delivery caused by events or circumstances beyond Leiters’ reasonable control.
5. INSPECTION, ACCEPTANCE, AND REJECTION OF PRODUCTS. Customer will have 48 hours from delivery to inspect Products (the “Inspection Period”). Any Product not compliant with the Specifications or Applicable Laws shall be deemed a “Defective Product”. If Customer intends to reject Products because such Products are Defective Products, it shall give notice in Writing within 24 hours after the Inspection Period expires; otherwise, Products shall be deemed accepted and may not be returned for any reason. Leiters will, at Customer’s option, either promptly replace at its cost any Defective Product or credit or refund any payments made by Customer for such Defective Product.
6. INVOICES. Leiters shall invoice Customer upon delivery as provided above. Customer shall pay the amount of each invoice within thirty (30) days of the date of invoice (with interest on past due amounts at the rate of 1.5% per month). Payment will be credited when the funds paid are available to Leiters without any restriction relating to the collectability of the funds received from Customer. If at any time, in Leiters’ sole discretion, Customer’s credit is impaired, Leiters shall have the right to require payment in advance before making any further shipment of Products. If Customer shall fail, within a reasonable time, to make such payment in advance, or if Customer shall fail to make payment when due, Leiters shall have the right, at its option, to suspend further deliveries hereunder until such failure is corrected, without thereby releasing Customer from its obligations under the Contract.
7. FAILURE TO TAKE DELIVERY. If Customer fails or refuses to take delivery, Customer shall be billed at that time for all unshipped Product, and on the first of each month thereafter for reasonable administration and storage costs. For each such shipment of undelivered Product, Customer agrees that: (a) Customer has made a fixed commitment to purchase such Product; (b) risk of ownership for such Product shall be borne by Customer; (c) such Product shall be on a bill-and-hold basis for legitimate business purposes; and (d) if no delivery date is determined at the time of billing, Leiters shall have the right to ship such Product to Customer within four (4) months after billing.
8. RECALLS. In the event that a recall, withdrawal or field correction of any Product (a “Recall”) is initiated, whether by a statutory or Regulatory Authority in any jurisdiction (including the FDA, state boards of pharmacy, and state controlled substance boards), Leiters shall comply with all requirements of such statutory or Regulatory Authority with respect to such Recall (provided that Customer shall reasonably cooperate with Leiters in connection with any Recall).
9. MUTUAL REPRESENTATIONS AND WARRANTIES. Each Party hereby represents, warrants, and covenants to the other party as follows: (a) such Party is and will remain duly organized, validly existing, and in good standing under the laws of the state in which it is organized, has and will continue to have the power and authority and legal right to own and operate its property and assets and to carry on its business as it is now being conducted, and does and will exercise its rights and perform its obligations hereunder in compliance with all requirements of Applicable Laws; (b) such party has and will continue to have the power and authority and the legal right to enter into the Contract and to perform its obligations thereunder and has taken all necessary action on its part to authorize the execution and delivery of the Contract and the performance of its obligations thereunder; (c) the Contract has been duly executed and delivered on behalf of such party and constitutes the legal, valid, and binding obligation of such party enforceable against such party in accordance with its terms; (d) all necessary consents, approvals, and authorizations of Regulatory Authorities and any other third parties required to be obtained by such party in connection with the execution, delivery, and performance of the Contract by such party have been obtained; and (e) the execution and delivery of the Contract by such Party, the exercise by such party of its rights thereunder, and the performance by such party of its obligations thereunder do not and will not contravene or conflict with such party’s organizational documents, contravene or conflict with or constitute a violation of any Applicable Laws, or breach or constitute a default under or conflict with the provisions of any contract, agreement or instrument to which it is a party or by which it is bound.
10. REPRESENTATIONS AND WARRANTIES OF LEITERS. Leiters hereby represents, warrants and covenants as follows: (a) Leiters has and shall maintain in good standing all required regulatory clearances, approvals, licenses, permits, and other authorizations necessary to Supply the Product(s) in compliance with Applicable Laws; (b) all Product(s) delivered to Customer hereunder shall have been Supplied by Leiters in compliance with these Conditions, the Specifications, cGMP, and all Applicable Laws; and (c) Leiters has and will convey to Customer good title to all Product(s), free from any security interest, restriction, reservation, lien, or other encumbrance whatsoever.
11. REPRESENTATIONS AND WARRANTIES OF CUSTOMER. Customer hereby represents, warrants, and covenants to Leiters as follows: (a) Customer has and shall maintain in good standing all required regulatory clearances, approvals, licenses, permits, and other authorizations necessary to order, possess, prescribe, administer, dispense, and/or dispose of the Product(s), as applicable, in compliance with Applicable Laws; and (b) by submitting an order for any Product: (i) Customer acknowledges that the bulk drug substance or API of such Product is also a component of an FDA-approved drug (or a Covered OTC Drug Product) and, accordingly, hereby represents and warrants, for itself and on behalf of each health care practitioner who may prescribe such Product (a “Prescribing Practitioner”), that such Product will be administered or dispensed only to patients for whom the change between the Product and the FDA-approved drug (or Covered OTC Drug Product) produces a clinical difference, as determined by such Prescribing Practitioner (it being understood and agreed that Customer shall obtain from such Prescribing Practitioner and provide to Leiters a statement of such clinical difference, and receipt by Leiters of such statement shall be a condition to the obligation of Leiters to deliver the Product to Customer); and (ii) Customer further represents and warrants that it is able to make the representation and warranty set forth in the foregoing clause (i) on behalf of each Prescribing Practitioner.
12. LIMITATIONS. THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THE FOREGOING SECTIONS 9, 10, and 11 ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY EACH PARTY TO THE OTHER, AND NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS, WARRANTIES, OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE.
13. INDEMNIFICATION. Each of Leiters and Customer (in either case, the “Indemnifying Party”) shall indemnify and hold harmless the other party and its directors, officers, employees, Affiliates, stockholders, members, agents, attorneys, representatives, successors and assigns (collectively, the “Indemnified Parties”) from and against any and all losses, damages, costs and expenses (including reasonable attorneys’ fees) (“Losses”) arising from or in connection with any claim, demand, assessment, action, suit or proceeding by any third party (a “Claim”) suffered or incurred by any Indemnified Party arising out of or resulting from: (a) any misrepresentation or breach of warranty made by the Indemnifying Party in the Contract; (b) any breach of any covenant or agreement made or to be performed by the Indemnifying Party pursuant to this Contract; or (c) the negligence or willful misconduct of the Indemnifying Party; except in each case, to the extent any such Loss arises out of or results from any Indemnified Party’s negligence, willful misconduct, or breach of the Contract.
14. LIMITATIONS OF LIABILITY. LEITERS’ TOTAL LIABILITY TO CUSTOMER, WHETHER IN CONTRACT OR TORT, SHALL IN NO EVENT EXCEED THE TOTAL PRICE PAID BY CUSTOMER TO LEITERS PURSUANT TO THE ORDER RELATING TO THE SUPPLY OF PRODUCT GIVING RISE TO THE CLAIM. EXCEPT WITH RESPECT TO PERSONALLY IDENTIFIABLE INFORMATION, A PARTY’S FRAUD, OR DEATH OR PERSONAL INJURY CAUSED BY SUCH PARTY’S NEGLIGENCE, IN ANY DISPUTE ARISING OUT OF THE CONTRACT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR TO ANY OTHER PERSON OR ENTITY FOR ANY SPECIAL, EXEMPLARY, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES OF ANY KIND OR NATURE WHATSOEVER (INCLUDING, WITHOUT LIMITATION, LOST REVENUES, PROFITS, SAVINGS OR BUSINESS, OR LOSS OF RECORDS OR DATA), WHETHER IN AN ACTION BASED ON CONTRACT, WARRANTY, STRICT LIABILITY, TORT (INCLUDING, WITHOUT LIMITATION, NEGLIGENCE) OR OTHERWISE, EVEN IF SUCH PARTY HAS BEEN INFORMED IN ADVANCE OF THE POSSIBILITY OF SUCH DAMAGES AND EVEN IF SUCH DAMAGES COULD HAVE BEEN REASONABLY FORESEEN BY ANY PARTY, AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY. NOTWITHSTANDING THE FOREGOING, THE LIMITATIONS SET FORTH IN THIS SECTION SHALL NOT IN ANY RESPECT LIMIT A PARTY’S OBLIGATIONS AND LIABILITY UNDER SECTION 13 (INDEMNIFICATION).
15. ASSIGNMENT. Leiters may assign a Contract or any part of it, or subcontract any of its obligations under the Contract, to any person, firm or entity. Customer shall not be entitled to assign a Contract or any part of it without the prior written consent of Leiters.
16. NOTICES. Any notice required or permitted to be given by either Party to the other shall be in Writing addressed to the other Party at its registered office or principal place of business or such other address as may at the relevant time have been provided pursuant to this provision to the Party giving the notice and shall be effective on the business day of actual receipt or, if received otherwise than on a business day, on the next business day.
17. WAIVER. No delay on the part of Leiters or Customer in exercising any right, power or privilege hereunder shall operate as a waiver thereof, nor shall any waiver on the part of either Party of any right, power or privilege hereunder operate as a waiver of any other right, power or privilege hereunder, nor shall any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder. Any provision of the Contract may be waived if, and only if, such waiver is in writing and signed by the Party against whom the waiver is to be effective.
18. SEVERABILITY. If any provision of these Conditions is held by any competent authority to be invalid or unenforceable in whole or in part, the validity of the other provisions of these Conditions and the remainder of the provision in question shall not be affected thereby.
19. ENTIRE AGREEMENT. The Contract constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersede all prior agreements, understanding and negotiations, both written and oral, between the Parties with respect to the subject matter of the Contract.
20. GOVERNING LAW. The Contract shall be governed by and construed in accordance with the laws of the State of Delaware excluding any choice of law rules which may direct the application of the law of another state.
21. FORCE MAJEURE. Neither Party will be liable to the other for any failure or delay in performance if the failure or delay is due to an act of God, war, riot, revolution, fire, explosion, sabotage, terrorism, accident, or casualty.
22. DEFINITIONS. As used herein: (a) “Act” means the U.S. Food, Drug, and Cosmetic Act, as amended; (b) “Affiliate” of a party means any corporation, firm, partnership, or other entity which controls, is controlled by, or is under common control with such party (and, for purposes of this definition, “control” means the ownership of more than fifty percent (50%) of the voting share capital of such entity or any other comparable equity or ownership interest); (c) “Applicable Laws” with respect to a Party means the international, federal, state, and local laws, rules, and regulations that are applicable to the conduct of such Party’s business and the performance of such Party’s obligations hereunder; (d) “cGMP” means the FDA’s current Good Manufacturing Practice requirements as promulgated under the Act at 21 CFR (parts 210 and 211), and as further defined by FDA guidance documents, as such may be amended from time to time, in each case as applicable to the compounding, manufacture, packaging, handling and storage of Product(s); (e) “Conditions” means the terms and conditions in this document; (f) “Contract” means an agreement in Writing between Customer and Leiters pursuant to which Leiters Supplies Product(s) to Customer in accordance with these Conditions and any Special Terms; (g) “Covered OTC Drug Product” means any marketed drug not subject to Section 503(b) of the Act (i.e., non-prescription drugs) and not subject to approval in an application submitted under Section 505 of the Act; (h) “FDA” means the U.S. Food and Drug Administration; (i) “Product” means the drug preparation or product that is compounded (or to be compounded) by Leiters under Section 503B of the Act and that is the subject of a Leiters quotation and/or Customer order, as contemplated by these Conditions; (j) “Regulatory Authority” means any federal, national, supranational, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the testing, compounding, manufacture, use, storage, import, promotion, marketing and sale of a Product in a country; (k) “Special Terms” means any special terms and conditions of the Contract agreed in Writing by Customer and Leiters; (l) “Specifications” means Customer’s specifications for the Product(s) set forth in the applicable order (or in a Leiters quotation upon which such order is based); (m) “Supply” means the compounding, manufacturing, packaging, labeling, quality control, testing, preparing for shipment and selling of Products; and (o) “Writing” means any written communication (including fax and e-mail) between Leiters and Customer.